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510(k) K060289

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 by Frontline Medical — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2006
Date Received
February 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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